N/A
Completed N=37
Biocontainment Device for Aerosol Generating Procedures
Protective Device (Physical Object) · Aerosol Disease · Droplet Spread
Source: ClinicalTrials.gov NCT04532112 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. — 46; 37 time (seconds)
Summary
The primary goal of this study is to assess use of a biocontainment device for planned airway procedures under general anesthesia. This will serve as a platform for using this device as a novel biocontainment and aerosol evacuation system as part of rapid sequence intubation protocols for COVID-19 patients. We hypothesize that airway procedures with the aerosol biocontainment device will be safe and effective with airway procedure times approaching times for airway procedures without the device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. |
46; 37 | — |
| PRIMARY Quantifying the Number of AEs or ADEs to Assess Device Safety. |
3; 0 | — |
| SECONDARY Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort. |
3 | — |
| SECONDARY Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device. |
4 | — |
| SECONDARY Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device. |
4 | — |
Eligibility Criteria
Inclusion Criteria
A) User (healthcare worker):
- Anesthesiologist, anesthesia resident, or CRNA at the Hospital of the University of Pennsylvania or PPMC who has signed and dated informed consent.
B) Patient:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- ASA I, II, III
- Undergoing planned procedure involving an airway procedure under general anesthesia
Exclusion Criteria
A) User (healthcare worker):
- Pregnancy due to potential risks from lifting the device.
B) Patient:
- Known history of difficult airway
- Anticipated difficult airway management for any reason
- COVID-19 positive status
- Pregnancy
- Planned prolonged intubation post-surgery or anticipated inability to answer patient questionnaire within 1 week of intubation.
Data sourced from ClinicalTrials.gov (NCT04532112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.